Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Severe Mood Dysregulation Clinical Trial

Official title:

Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591564
• Other study ID #: NA_00046454
• Secondary ID: K23MH090246
• Status: Completed
• Phase: N/A
• First received: May 2, 2012
• Last updated: March 30, 2015
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD).

The investigators hypothesize that retention rates will be >80%,satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD intervention will have overall improvement in SMD symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria.

• Subject has an estimated IQ >70 on the Kaufman Brief Intelligence Test (KBIT-2)

• Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.

• Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization.

• Children's Global Assessment Scale (CGAS) = 60

Exclusion Criteria:

• Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.

• Subject suffers from a concomitant medical or psychiatric co-morbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).

• Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).

• Pregnant females.

• Primary caretaker does not speak English

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Severe Mood Dysregulation

Intervention

Behavioral:
• Interpersonal Psychotherapy for youth with SMD (IPT-SMD)
Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.	20 weeks	No
Secondary	Clinical Global Impressions Scale CGI-I (SMD)	We will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.	20 weeks	No